1. Field of the Invention
The present invention relates to improvements in the procedure for suturing tissue during endoscopic/laparoscopic surgery, and to a method of suturing which utilizes a modified laparoscopic grasper and a guide. More particularly, the improved method relates to suturing of ligaments using a needle-point suture passer to retract and reinforce the ligaments, applications including uterine suspension and positioning. Devices suitable for insertion into ligaments or tendons for retracting and reinforcing the same in accordance with the improved method are also disclosed.
2. Description of the Related Art
An endoscopic/laparoscopy procedure involves making small surgical incisions in a patient""s body for the insertion of trocar tubes thereby creating access ports into the patient""s body. Thereafter, various types of endoscopic/laparoscopic instruments are passed through these access ports and the appropriate surgical procedures are carried out.
After the surgical procedure is performed, the trocar tubes are removed and the incisions sutured closed by using both a needle and grasper for penetrating the tissue and handling the suture. This procedure for closure is frequently a time-consuming procedure requiring the identification of the fascia and closure of each fascial site with suture from an external point.
The necessity for closing these port sites in laparoscopic surgery is critical since suturing the incisions improperly can lead to bowel herniation through the port sites as well as the possibility of omental trapping if the fascial sites are not properly closed. Incisional hernias have occurred in both laparoscopic-assisted vaginal hysterectomies and laparoscopic cholecystectomies as well as other advanced laparoscopic procedures.
Thus there is a need for an endoscopic/laparoscopic instrument and method which will significantly reduce the operating time and is better able to give the surgeon direct visualization of the fascial and peritoneal closing. Additionally, there is a need for a surgical instrument which allows the surgeon to control bleeding sites by rapidly putting sutures around blood vessels of the abdominal wall.
Furthermore, there is a need to accurately and consistently guide and orient an endoscopic/laparoscopic instrument into proper position to accurately and easily provide for placement and retrieval of suture materials within an open wound to be closed.
The subject invention herein solves all of these problems in a new and unique manner which has not been part of the art previously. General types of surgical forceps and laparoscopic graspers are known in the art, and some related patents directed to surgical instruments or guides are described below:
U.S. Pat. No. 5,192,298 issued to W. Smith et al. on Mar. 9, 1993
This patent is directed to a disposable laparoscopic surgical instrument. The laparoscopic surgical instrument comprises a tube surrounded by a peripheral insulating shrink-wrap layer, a clevis means, effectors pivotally engaged to the clevis at a pivot pin, and activating means. The effectors are provided with blades or graspers which taper to a point and are rotatably mounted on the pivot pin.
U.S. Pat. No. 5,201,743 issued to T. Haber et al. on Apr. 13, 1993
This patent is directed to an axially extendable endoscopic surgical instrument. The endoscopic surgical instrument includes an elongate body, a tip carrier tube, a tip assembly removably mounted to the distal end of the carrier tube and having a pair of movable jaws, a driver assembly which causes jaws to move between open and closed positions, and a jaw-rotating assembly which causes the tip assembly and jaws therewith to rotate about an axis. The jaws taper substantially at their distal ends, and the interior surface of the jaws are serrated.
U.S. Pat. No. 4,950,273 issued to J. M. Briggs on Aug. 21, 1990
This patent is directed to a cable-action instrument. The instrument comprises a controller, a reaction end, and an angle adjustment section which connects the controller to the reaction end, and a flexible control cable assembly extending between the controller and the reaction end. The reaction end consists of a scissors tip having a stationary blade and a cable-activated blade, both of which have pointed distal ends. A forceps instrument tip having a stationary clamp arm and a cable-activated clamp arm may be substituted for the scissors tip.
U.S. Pat. No. 4,938,214 issued to P. Specht et al. on Jul. 3, 1990
This patent is directed to a hand-held surgical tool. The surgical tool includes an operating end having first and second blade tips which are movable between open and closed positions. When the blade tips are closed, the surgical tool has a needle-sharp point having a diameter of only about 50 microns to 2 mm.
U.S. Pat. No. 3,577,991 issued to G. R. Wilkinson on May 11, 1971
This patent is directed to a tissue-sewing instrument. The forceps are pivoted together with the outer jaws and a spring set between the members. The thread slides to the end of the forceps, and the free end of the thread is pulled through the loops to make a knot.
U.S. Pat. No. 5,196,023 issued to W. Martin on Mar. 23, 1993
This patent is directed to a surgical needle holder and cutter wherein the cutter forming the upper part of the blade has a concave shape. When the forceps jaw is opened, an approximately elliptical opening is formed between the ridge, or cutter, and the depression into which a thread may be brought from the direction of the opening of the forceps jaw and then can be cut off by closing the jaw.
U.S. Pat. No. 5,222,508 issued to O. Contarini on Jun. 29, 1993
This patent is directed to methods for closing punctures and small wounds of the human body, allowing such punctures to be sutured and closed with an internal seal. Before the trocar is removed, a suture insertion means, a needle preferably of stainless steel, having an eyelet or a slot or barb to retain the suture material, is pushed completely through the skin and subcutaneous layer. A retrieval means is inserted adjacent the puncture so its barbed portion grasps or snares the free end of the suture material. The insertion needle, retrieval needle, and trocar are withdrawn and the suture drawn tight.
U.S. Pat. No. 5,053,043 issued to J. Gottesman et al. on Oct. 1, 1991
This patent is directed to a suture guide with interchangeable tips for placing sutures in the severed end of a body duct. Various tips having one or more apertures and channels for placing sutures are provided to screw into an elongate member. The elongate member has a handle at the opposite end. This guide is particularly useful for the placement of sutures into the urethral stump.
U.S. Pat. No. 5,201,744 issued to M. W. Jones on Apr. 13, 1993
This patent is directed to a method and device for suturing using a rod with a needle holder. This device, a knot-tier instrument, has a rod with an end having notches for guiding suturing threads, and a slot for holding a needle. The end may be magnetized to aid in magnetically holding the needle in the slot. A hollow cannula, or access tube, can be inserted through the skin, and the knot tier inserted into the cannula for suturing the wound closed.
U.S. Pat. No. 5,176,691 issued to J. Pierce on Jan. 5, 1993
This patent is directed to a plurality of embodiments of knot pushers formed from elongated rods. The pusher with an elongated rod has various configurations to guide suture ends and push the knot. The end of the rod has a face shaped to push the knot, and near the edges of the rod are eyelets or grooves or the like to guide the sutures as the knot is being pushed. The purpose of the device is to advance the knot of a suture through an endoscope portal or a cannula or the like.
U.S. Pat. No. 4,621,640 issued to J. S. Mulhollan on Nov. 11, 1986
This patent is directed to a mechanical needle carrier which can grasp and carry a surgical needle through a cannula, position the needle, and set a stitch at a remote location, then release the needle for withdrawal from the cannula. The mechanical needle carrier is inserted through the cannula, and a pivotal needle-carrying head is positioned by adjusting knurled knobs so as to position the needle as required. Once the needle is set, it can be released and then retrieved by forceps or the like. This mechanical needle carrier provides the structure for suturing in a restricted field with the manipulation remote from the location of the needle.
Intra-abdominal suturing is a time-consuming process for surgeons in part because a lot of manipulation and xe2x80x9cfiddlingxe2x80x9d is associated with the needle attached to the suture material. For instance, the needle and suture material must be aligned so they can pass through a trocar sleeve. As curved needles will only fit through large trocar sleeves, larger wounds must be made for the trocars in order to pass the curved needles into the body cavity. Once inside the abdominal cavity, the needle has to be grasped, regrasped, aligned, and realigned in the needle driver. After each stitch, the needle has be to be grasped and realigned in the needle driver.
With the present invention, the needle driver and the needle are one and the same. Therefore, the disadvantages presented by having an independent needle are avoided. Suturing can start immediately without the frustration of continually realigning the needle when it is regrasped. The surgeon simply passes the suture through the tissue then, by either using the same instrument or a standard grasper, picks up the suture for tying or passing through the tissue to create another stitch for wound closure. The present invention allows introduction of suture directly through tissue or through small trocar sites, as the diameter of the shaft and its tip for the probe is generally much smaller than the average trocar. Additionally, the technique for using the present invention is easily learned; and the several embodiments set forth herein generally reduce the time and frustration associated with intra-abdominal suturing. These advantages are enhanced by use of the guide disclosed herein.
Laparoscopic surgical procedures have been used in attempts to correct misalignment of a woman""s uterus. This misalignment is most often seen as a retroverted, backward-bending uterus, but can also be an anterior misalignment where the uterus is situated more toward the front than is desired. Symptoms reported as a result include chronic pelvic pain, pain on intercourse, debilitating pain during menstrual cycles, urinary problems, bowel problems, infertility and back pain.
It has been found that repositioning the uterus to a more midline position in the pelvis relieves symptoms in a great percentage of these patients. To that end a number of surgical procedures have been attempted to perform the correction.
The corrections revolve around surgeons"" observations that ligaments, or tough bands of tissue which normally function to hold the uterus in a neutral position, are or have become stretched, thinned or loosened from their attachment points. Procedures designed to shorten and/or reattach these ineffective ligaments include the following:
Gilliams Procedure
The Gilliams procedure was designed to remove a section of the ligament and suture the ends back together. The resulting shortened ligaments provide more tension to hold the uterus in a neutral position. Among the drawbacks to Gilliams procedure is that it does nothing to improve the strength of thinned ligaments and they may again stretch so that the correction would be short-lived. Additionally, Gilliams procedure can change the geometry of the lower pelvis when ligaments are reattached to the anterior abdominal wall, creating a pouch that may entrap the bowel which is a serious complication.
Webster-Baldy Procedure
The Webster-Baldy procedure creates a new attachment point for one ligament by passing it through another and suturing it to the wall of the lower uterine corpus. This stretching of the ligament to a second attachment point on the uterus creates more tension with which to hold the uterus. This correction does not take advantage of the thickest part of the ligament which is the part already attached to the uterus. Changing the attachment point does nothing to improve the strength of these thinned ligaments, and they may be prone to restretch.
Mann-Stenger Uterine Suspension, Candy""s Modified Gilliam Uterine Suspension, Pereyra Needle Uterine Suspension, Doleris""s Procedure
The above procedures rely on passing suture one or more times around or through the ligament and then directly attaching the loose ends of suture to the abdominal wall for the purpose of putting more tension on the ligaments that support the uterus. The procedures do not reinforce thinned ligaments which may stretch and loosen from the fixation. They also create a cavity-like space in the anterior cul-de-sac where bowel intussusception will be most likely to occur. This may lead to a slipping of a length of intestine into an adjacent portion, which may produce an obstruction.
In contrast, the present invention uses a needle-point suture passer to carry and withdraw suture longitudinally into the ligament from a point at or near the ligament""s original fixation point. Using this method, the thinned part of the ligament is reinforced with permanent suture, thus significantly reducing the risk of additional stretching. By tunneling into the ligament from the area near the natural attachment point, the natural geometry of the lower pelvis is preserved which reduces the risk of complications.
In accordance with the improved method for retracting and/or reinforcing ligaments to better support organs, there may be other ways to accomplish the same rather than only routing suture in and out of the ligament as described above. For example, it may be desirable to invest specially configured devices into a ligament to accomplish the retracting and/or reinforcing.
It has been known in the art to use splints or other devices to repair lacerated or severed ligaments or tendons, or for use in place of badly damaged connective tissues. The prior art devices may include anchoring or securement structures for fixing the device in a ligament or tendon, or for securing the device with sutures to the ligament or tendon. Typically the devices are used to hold together opposing ends or portions of connective tissue, while preparing for and waiting for the healing process. Often the devices are made of materials which are at least partially absorbed into the body over time, such that they need not be removed once healing of the connective tissue has taken place. As evident from the above description, the prior art devices are not suitable for use to retract and reinforce ligaments to better support organs as envisioned by Applicant.
The present invention is directed to a suturing method using an improved laparoscopic surgical instrument which permits a surgeon to pass suture without trauma through tissue while retaining the function of grasping the suture. The laparoscopic surgical instrument comprises a modified laparoscopic grasper wherein forceps jaws at the tip are manipulated by means of handles extending from a tubular housing with an enclosed reciprocating actuating rod connected with the handles. As contemplated in the present invention, scissor-type or syringe-type handles may be used. In an alternative embodiment, a cannula may be used.
The laparoscopic surgical instrument of the present invention has the tip of the forceps jaws modified to have either a knife-, chisel-, or cone-shaped tip when the jaws are in the closed position. These tips are configured such that they are needle sharp which is critical in reducing trauma and accompanying bleeding and further decreases tissue damage during the suturing procedure. Other tip configurations include curved and bent tips, which allow greater facility under certain conditions. Additionally, a suture probe guide delivering guided access to appropriate tissue layers for suturing is provided.
The method of the present invention to shorten and strengthen a ligament includes entering the person""s body with a surgical tool having a sharp tip and bearing suture material, and inserting the tool into the ligament and pushing the suture material along the axial length of the ligament. Then the method includes pulling the suture from outside the ligament causing the ligament to retract along its length, and incorporating the suture material such that the ligament is retracted and reinforced. The resulting ligament is shorter, thicker and stronger, and better able to support internal organs such as a woman""s uterus.
Rather than using only suture materials to shorten and strengthen connective tissue such as ligaments, tendons, etc., devices for investment into connective tissues are also contemplated. The devices of the present invention for such uses as insertion into the round ligament to better support a woman""s uterus, include an elongate body having one or more spaced-apart anchors adapted to be fixed to the connective tissue in a retracted condition, to hold the connective tissue in the retracted condition. The elongate body of the device may include a deployable anchor at the first end inserted into the ligament, and the opposing end of the device may be attached to a nearby fixed structure of the human body. Alternatively, both ends of the device may include one or more opposing anchors or scales adapted to firmly hold the ligament in the retracted condition.
Other alternate embodiments are contemplated, including a device having an elongate substantially rigid body adapted to be screwed into place inside the ligament in a retracted condition. Or the device may include an elongate body extendable to a substantially straight configuration inside the ligament, and retractable to a substantially coiled configuration to hold the ligament in a retracted condition. A device in combination with suture or glue could also be used to hold the ligament in the retracted state.
It is an object of the invention is to provide a surgical method for the closure of a surgical incision under direct camera laparoscopic vision of the surgeon, and the closure that is accomplished is a mass closure which allows for closure of peritoneal surfaces as well.
A further object of the invention is to provide a laparoscopic instrument that allows for the rapid control of bleeding from inferior epigastric lacerations or other lacerations of vessels in the outer (or abdominal) wall that may occur with placement of the laparoscopy trocars.
Another object of the invention is to provide a laparoscopic instrument that easily disassembles at the handle and at the interface between the tube member and handle for providing easy access to all the instrument components for cleaning and sterilization prior to surgery.
Still another object of the invention is to provide a laparoscopic instrument having a pair of independently operated actuatable means such that a single instrument can simultaneously perform both the functions of a needle and grasper during laparoscopic surgery.
Yet another object of the present invention is to provide a surgical instrument that works in a manner similar to a needle driver without the requirement for the needle itself in passing suture easily through the fascial and peritoneal surfaces and for retrieving the suture for completing the suture procedure in a rapid, safe, and visualized manner.
It is another object of the invention to provide a guide to accurately and consistently restrain the position and angle of insertion of a laparoscopic instrument to provide for proper placement and retrieval of suture material at a predetermined location within the body.
Accordingly, it is an objective of the present invention to provide a method associated with an improved surgical instrument of the standard laparoscopic-type grasper that better suits the needs of a surgeon when suturing closed a surgical incision. In addition, it is the objective of the present invention to allow the passage of suture through tissue in order to suture or ligate vessels, approximate tissues, and perform all suturing that would require a separate needle driver in laparoscopic surgery.
Another object of the invention is to provide a method of laparoscopically inserting a suture within a ligament in a person""s body, causing the ligament to retract along its length and reinforcing the ligament.
Still another object of the invention is to provide a method of laparoscopically suturing the round ligament that supports a woman""s uterus to shorten and strengthen the ligament to reposition and stabilize a misaligned uterus.
Finally, still another object of the invention is to provide a method of laparoscopically suturing the round ligament that supports the woman""s uterus and anchoring the same to a bone, to reposition the uterus.
Another object of the present invention is to provide a device for investment into connective tissue of the human body to firmly hold the connective tissue in a retracted condition.
Another object is to provide such a device adapted to facilitate insertion into connective tissue and adapted to firmly hold the connective tissue once retracted.
Another object is to provide such a device which automatically deploys once inside connective tissue.
Another object is to provide such a device that need not be sutured into place inside the connective tissue.
The improvements afforded by this instrument, and the methods and devices of the present invention are set forth throughout the following description, claims, and accompanying drawings.